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Protocol # 17-334

Status

Recruiting

Description

This clinical study will assess the safety and tolerability of escalating intratumoral doses of mRNA-2416 alone and in combination with intravenously administered flat doses of durvalumab in patients with relapsed/refractory solid tumor malignancies or lymphoma, as well as the objective response rate (ORR) of mRNA-2416 alone or in combination with durvalumab in ovarian cancer based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Condition

  • Relapsed/Refractory Solid Tumor Malignancies or Lymphoma
  • Ovarian Cancer

Interventions

  • mRNA-2416
  • Durvalumab

Phase

Phase 1/Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Percentage of subjects with dose limiting toxicities (DLTs) with mRNA-2416 alone
  • Percentage of subjects with dose limiting toxicities (DLTs) with mRNA-2416 in combination with durvalumab
  • Percentage of subjects with adverse events (AEs) for mRNA-2416 alone
  • Percentage of subjects with adverse events (AEs) for mRNA-2416 in combination with durvalumab
  • In Phase II dose expansion: objective response rate (ORR) of mRNA-2416 alone and in combination with durvalumab in patients with ovarian cancer based on RECIST v1.1

Secondary Outcome:

  • Percentage of subjects with anti-OX40L antibodies
  • Maximum Observed Serum Concentration (Cmax) of mRNA-2416
  • Maximum Observed Serum Concentration (Cmax) of mRNA-2416 alone
  • Area under the serum concentration-time curve (AUC) of mRNA-2416 alone
  • Area under the serum concentration-time curve (AUC) of mRNA-2416 in combination with durvalumab
  • In Phase I only: ORR based on RECIST v1.1 or Cheson 2014 criteria (lymphomas)
  • In Phase I only: duration of response based on RECIST v1.1 or Cheson 2014 criteria (lymphomas)
  • In Phase I only: progression-free survival based on RECIST v1.1 or Cheson 2014 criteria (lymphomas)
  • Disease control rate in patients with ovarian cancer (RECIST v1.1)
  • In Phase II: disease control rate in patients with ovarian cancer (RECIST v1.1)
  • In Phase II: duration of response in patients with ovarian cancer (RECIST v1.1)

Enrollment

117

Study Start Date

August 9, 2017

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

ModernaTX, Inc.

Source

ModernaTX, Inc.

Official title

A Phase 1/2, Open-Label, Multicenter, Dose Escalation and Efficacy Study of mRNA 2416, a Lipid Nanoparticle Encapsulated mRNA Encoding Human OX40L, for Intratumoral Injection Alone or in Combination With Durvalumab for Patients With Advanced Malignancies

Clinicaltrials.gov Identifier

NCT03323398

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.